We are looking for a highly skilled and experienced Regulatory Submission Specialist to join our team at a reputed pharmaceutical company in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a robust background in regulatory affairs and submission preparation.

Roles and Responsibility
Prepare and review regulatory submissions, including clinical trial applications, marketing authorizations, and periodic safety update reports.
Ensure compliance with relevant regulations, guidelines, and standards.
Collaborate with cross-functional teams, including R&D;, quality assurance, and legal affairs.
Develop and maintain relationships with regulatory authorities and stakeholders.
Stay updated with changing regulatory requirements and implement necessary changes.




Provide training and guidance to junior staff on regulatory affairs and submission preparation.

Job Requirements
Bachelor's degree in Pharmacy or related field; advanced degree preferred.
Minimum 5 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
Robust knowledge of regulatory requirements, guidelines, and standards.
Excellent communication, writing, and interpersonal skills.
Ability to work independently and as part of a team.
Proficient in regulatory software and systems.

📌 Regulatory Submission Specialist Mumbai
🏢 Naukri Healthcare Jobs
📍 Mumbai